Edwards Lifesciences (NYSE:EW) yesterday released results from 3 trials of its surgical heart valves designed for treating aortic valve disease, touting positive clinical results from studies of over 2,000 patients.
Data from the trials was presented during late-breaking sessions at the American Association for Thoracic Surgery’s 96th annual meeting this week, the company said.
“Edwards is proud to lead the innovation of heart valve therapies to address a broad range of patient needs around the world, and these compelling new data on more than 2,000 patients provide important clinical evidence on the benefits of new surgical treatments. We are committed to expanding our surgical heart valve portfolio with meaningful innovations and by continuing to work in partnership with surgeons to meet the needs of patients who suffer from a variety of heart valve diseases,” surgical heart valve therapy corporate veep Bernard Zovighian said in a press release.
Edwards presented 1-year data from the 674-patient Commence pivotal trial of its surgical aortic valve featuring Resilia tissue, touting no cases of structural valve deterioration, valve thrombosis or nonstructural valve dysfunction.
“The early clinical results with the new valve with Resilia tissue in this multicenter, international FDA trial are encouraging and set a high benchmark for surgical aortic valve replacement. The Resilia tissue has the potential to create a new class of surgical tissue valves that pre-clinical studies have shown to offer key benefits, such as significantly reduced calcification and sustained hemodynamics,” Commence study principal investigator Dr. John Puskas of New York’s Mount Sinai Health System said in a prepared release.
The company reported data from the 839-patient Transform pivotal trial, touting 1-year data from its Intuity valve system which reported reduced cross-clamp time and cardiopulmonary bypass time compared to recorded times in the Society of Thoracic Surgeons’ adult cardiac database.
Edwards said the results, which evaluated both its 1st and 2nd-gen Intuitive valves, may indicate decreased mortality and morbidity, shorter ICU and overall hospital stays
In a separate presentation, the company said data from the 493-patient Foundation registry study indicated that patients treated with its 1st-gen Intuitive valve system in Europe demonstrated “excellent safety and effectiveness” at 1 year.
“There is a clinical need for innovative surgical heart valve therapies to ensure patients receive the appropriate treatment, and the Edwards Intuity Elite valve system is designed to facilitate minimally invasive surgery and streamline complex aortic valve replacements, which is a major advancement,” Transform trial co-primary investigator Dr. Walter Chitwood of Greenville, N.C.’s East Carolina University said in prepared remarks.
Edwards said its 2nd-gen Intuitive elite valve system won CE Mark approval in the European Union in 2014, but did not comment on its progression towards FDA regulatory clearance in the U.S.